Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
- Recall Initiated
- August 1, 2005
- Posted
- June 30, 2007
- Terminated
- August 4, 2009
- Recall Number
- Z-0603-2007
- Quantity
- 534 of both model numbers
- Firm Location
- Ann Arbor, MI
Reason for Recall
The power supply may fail to function due to a defective capacitor. (Note; this device incorporates a redundant separate power supply not affected by this capacitor)
Distribution
Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.
Lot / Code Info
Serial numbers 0006 through 0066 and 0100 through 0187 may be affected. Serial numbers 0046 and 0160 have been corrected.
Root Cause
Other
Action Taken
The power supplies were replaced as complaints were received between August 2005 and February 2006. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their units will be corrected when replacement components become available.